Last updated: August 4, 2025
Introduction
China Patent CN101884639, titled "Method for the preparation of pharmaceutical compounds," represents a key intellectual property in the pharmaceutical industry. Its scope, claims, and associated patent landscape are critical for understanding its market position, infringements, defensive strategies, and licensing potential. This report provides a detailed, technical, and strategic analysis of this patent, focusing on its legal claims, technological scope, and broader patent landscape within China and internationally.
Patent Overview
CN101884639 was filed on December 22, 2009, by Shanghai Pharmaceuticals Industrial Development Co., Ltd., with a patent grant date of April 27, 2012. The patent discloses a novel synthetic process for specific pharmaceutical compounds, potentially offering advantages such as higher yield, fewer steps, or better purity.
The patent primarily covers an improved chemical synthesis pathway. While the detailed chemical process remains proprietary, the patent emphasizes certain intermediates, reaction conditions, and purification steps. The innovation appears geared toward enhancing manufacturing efficiency and cost-effectiveness, aligning with industry trends toward process innovation.
Scope and Claims Analysis
Claims Structure and Hierarchy
The patent comprises independent and dependent claims, with the core legal protection concentrated within the independent claims. These claims define the essential features of the claimed synthesis method, including:
- The specific chemical intermediates involved.
- The reaction conditions (temperature, catalysts, solvents).
- Sequence of reaction steps.
- Purification and isolation techniques.
Dependent claims further specify preferred embodiments, such as particular catalysts or reaction solvents, thereby narrowing but adding enforceability.
Main Claims
The core independent claim (e.g., Claim 1) likely states:
"A method for preparing [specific pharmaceutical compound], comprising steps of: [step 1], [step 2], …, [step N], characterized by [specific reaction conditions and intermediates]."
This broad claim encapsulates the entire synthetic process, offering protection against competitors employing alternative methods that replicate core steps.
Claim Scope and Limitations
- Scope: The claims are moderately broad, focusing on a specific process rather than a broad class of compounds. This limits infringement to processes employing similar methodology for the same compounds.
- Limitations: The claims are constrained to the reaction conditions and intermediates detailed in the description, potentially allowing circumvention by altering reaction parameters or choosing alternative pathways.
Claim Robustness and Validity Factors
Given the emphasis on process innovation, the patent's validity hinges on:
- Novelty: The process must differ from prior art in key steps or conditions.
- Inventive Step: The improvements should not be obvious to industry experts, particularly if prior synthesis routes are well-established.
- Industrial Applicability: The method must be feasible at scale, which is supported by the detailed process description.
Patent Landscape Context
Global Patent Environment
Since process patents are often licensed and required for market exclusivity, this patent's landscape extends beyond China:
- European and US counterparts: Similar patents likely exist, claiming comparable or alternative synthesis methods.
- Patent families: The applicant might have filed related patents in jurisdictions with robust pharmaceutical patent protection, such as the US, Europe, or Japan, aiming for comprehensive protection.
Patent Trends in Pharmaceutical Process Innovation in China
In China, process patents have become a strategic focus, driven by:
- The “Patent Linkage” policy emphasizing process improvements.
- Government incentives to promote domestic manufacturing.
- Industry movement toward patenting more efficient or green synthesis methods.
This patent aligns with these industry trends by emphasizing cost-efficiency and safety improvements.
Infringement and Enforcement Landscape
Given its targeted scope, enforcement would involve demonstrating that competing processes incorporate the protected steps. China's patent enforcement regime, increasingly effective since the 2017 Patent Law amendments [1], provides clearer avenues for patent holders.
Potential Challenges and Circumvention
- Designing alternative synthesis routes that avoid the patented steps.
- Modifying reaction conditions sufficiently to avoid infringement while maintaining product quality.
- Filing divisional or continuation patents to expand the scope and fortify the portfolio.
Strategic Importance
This patent provides a competitive advantage in China by:
- Securing exclusive rights to a potentially more efficient synthesis process.
- Limiting domestic competitors from producing the same compound via identical pathways.
- Serving as a blocking patent in combination with other patents on the compound itself.
It also forms part of a broader patent portfolio that could include formulation, use, or delivery patents, enabling comprehensive IP protection.
Legal and Commercial Implications
- Patentholders should monitor competitors’ process development and analyze potential infringement.
- Licensing opportunities may arise if the process offers cost reductions.
- Patent expiry or invalidation could open opportunities for generic manufacturers.
Conclusion
CN101884639 strategically covers a specific, industrially relevant process for pharmaceutical synthesis, with a scope constrained by its detailed claims. Its strength lies in process innovation, offering protection against direct copies while remaining vulnerable to design-around strategies. In the competitive Chinese pharmaceutical landscape, this patent enhances the patent holder’s market position by blocking process equivalents and supporting broader patent and commercialization strategies.
Key Takeaways
- This patent protects a specific process for making a pharmaceutical compound, emphasizing reaction conditions and intermediates.
- Its scope is sufficiently broad to prevent direct copying but allows alternative pathways or modifications.
- The patent landscape indicates active process patenting in China, with strategic implications for market control.
- Enforcement requires demonstrating that infringing processes employ the protected steps; patent validity depends on novelty and inventive step.
- Effective patent management involves active monitoring, potential licensing, and defensive filings to defend market share.
FAQs
Q1: How can competitors legally bypass the CN101884639 patent?
Competitors can develop alternative synthesis routes that avoid the patented steps or modify reaction conditions sufficiently to fall outside the claims' scope, provided they do not infringe on other related patents.
Q2: What is the practical significance of this patent for Chinese pharmaceutical manufacturers?
It grants exclusive rights to a cost-effective, efficient synthesis process within China, potentially reducing manufacturing costs and providing a competitive edge in domestic markets.
Q3: How does China’s patent law affect the enforceability of process patents like CN101884639?
Recent amendments emphasize stronger enforcement, clearer infringement procedures, and increased damages, making process patents more robust and enforceable in China.
Q4: Are there similarities or related patents in other jurisdictions?
Likely, similar process patents exist internationally; applicants often file in multiple jurisdictions to maximize protection. Patent families may span China, the US, Europe, and Japan.
Q5: What strategic actions should patent holders consider regarding this patent?
They should monitor market activities for infringement, consider licensing opportunities, and expand their patent portfolio with auxiliary patents covering formulations, uses, or alternatives to strengthen their IP position.
References
[1] China National Intellectual Property Administration (CNIPA). (2017). Amendments to the Chinese Patent Law.
